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| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
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High flow nasal cannula (HFNC) is used in interventional procedures to prevent hypoxia during sedation. In patients with a patent airway, HFNC reduces dead space ventilation as well. It is unknown if dead space ventilation is also reduced by HFNC in an EndoBroncheal UltraSound procedure, in which the airway is partially blocked by the endoscope. Especially in patients with Chronic Obstructive Pulmonary Disease (COPD) the partial blocking of the airway may reduce ventilation. If HFNC is able to reduce dead space during an EBUS-procedure, it may facilitate CO2 clearance, which may lead to a reduction in work of breathing.
This study aims to investigate if HFNC reduces dead space ventilation in patients undergoing an EBUS-procedure and if this is flow-dependent.
A randomized, double-blinded, cross-over study is designed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 L - 70 L | Active Comparator | Initially, all patients will receive 3L/min of oxygen for 10 minutes. Than, patients in this arm will receive 30L/min of High Flow Nasal Oxygen for 15 minutes and subsequently 70 L/min for another 15 minutes. |
|
| 70 L - 30 L | Active Comparator | Initially, all patients will receive 3L/min of oxygen for 10 minutes. Than, patients in this arm will receive 70L/min of High Flow Nasal Oxygen for 15 minutes and subsequently 30 L/min for another 15 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THRIVE (High Flow Nasal Cannula) | Device | 2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory CO2 at 10 minutes (baseline) | Inspiratory CO2, measured at the carinal level | at t=10 minutes |
| Inspiratory CO2 at 25 minutes | Inspiratory CO2, measured at the carinal level | at=25 minutes |
| Inspiratory CO2 at 45 minutes | Inspiratory CO2, measured at the carinal level | at t=45 minutes |
| expiratory CO2 at 10 minutes (baseline) | Expiratory CO2, measured at the carinal level | at t=10 minutes |
| expiratory CO2 at 25 minutes | Expiratory CO2, measured at the carinal level | at t=25 minutes |
| expiratory CO2 at 45 minutes | Expiratory CO2, measured at the carinal level | t=45 minutes |
| Slope of capnography at 10 minutes (baseline) | Angle of the D-E segment (inspiratory slope) | At t=10 minutes |
| Slope of capnography at 25 minutes | Angle of the D-E segment (inspiratory slope) | At t=25 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory rate | Respiratory rate, measured by capnography | At t=10 minutes |
| Respiratory rate | Respiratory rate, measured by capnography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Miechels | Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem | Principal Investigator |
| Mark V Koning, MD, PhD | Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem | Study Chair |
| Niels Claessens, MD, PhD | Dept. of Pulmonology, Rijnstate Hospital, Arnhem | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | 6815 AD | Netherlands |
Upon reasonable request and within the limits of the law on patient data distribution.
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| ID | Term |
|---|---|
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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The patient is sedated and the investigators are blinded for the randomization. Only the care provider is aware of the randomisation.
|
| Slope of capnography at 45 minutes |
Angle of the D-E segment (inspiratory slope) |
| At t=45 minutes |
| At t=25 minutes |
| Respiratory rate | Respiratory rate, measured by capnography | At t=45 minutes |
| The level of HFNC dead space washout | Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level. | At t=10 minutes |
| The level of HFNC dead space washout | Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level. | At t=25 minutes |
| The level of HFNC dead space washout | Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level. | At t=45 minutes |